Attorney Brynn Stanley outlines provisions in a 2022 FDA draft cybersecurity guidance and how they differ from the 2018 draft it replaced.
Brainstorm Cell Therapeutics says it will submit a BLA for it NurOwn stem cell therapy for treating amyotrophic lateral sclerosis.
FDA commissioner Robert Califf tells FDA Webview his agency is joining with other entities, especially universities, to form a new ecosystem to find s...
Federal Register notice: FDA makes available a final guidance entitled Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplificatio...
Cancer researchers say circulating tumor DNA may be an important tool in clinical development and an early indicator of treatment benefit.
Four stakeholders request clarification of parts of an FDA draft guidance on clinical pharmacology considerations for human radiolabeled mass balance ...
Two stakeholders request changes to an FDA draft guidance on risk management plans to mitigate the potential for drug shortages.
FDA posts a draft guidance entitled Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations Premarket Notification (510(...
